HealthyPhase 1NCT02243319
Investigating the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904
A Phase 1 study testing HGP1201, HGP0904 and HGP0904 and HGP1201 co-administraion in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904 Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HGP1201, HGP0904 and HGP0904 and HGP1201 co-administraion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteer, age 19~45 years
- The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
Who cannot join
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
- History of relevant drug allergies or clinically significant hypersensitivity reaction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904 in Healthy Male Subjects
The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904
Read the detailed description
Randomized, open-label, multiple dose , 3-treatment, 6-sequence, 3-period, crossover study, The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904
- Conditions
- Healthy
- Being tested
- HGP1201, HGP0904, HGP0904 and HGP1201 co-administraion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGP1201Drug
HGP0904Drug
HGP0904 and HGP1201 co-administraionDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | A → B → C
A: HGP1201 for 9 days B: HGP0904 for 9 days C: HGP1201+ HGP0904 for 9 days Receives: Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion |
| Group 2 | Experimental | C → A → B Receives: Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion |
| Group 3 | Experimental | B → C → A Receives: Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion |
| Group 4 | Experimental | C → B → A Receives: Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion |
| Group 5 | Experimental | B → A → C Receives: Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion |
| Group 6 | Experimental | A → C → B Receives: Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss of HGP1201, HGP0904
Measured: 1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h
AUCτ,ss of HGP1201, HGP0904
Measured: 1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyeong-Seok Lim, MD PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243319
- Sponsor's protocol ID
- HM-TARO-101
- Status last verified
- Oct 2016
- First submitted
- 24 Aug 2014
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02243319
- Acronym / sponsor ID
- HM-TARO-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904
Detailed description
Randomized, open-label, multiple dose , 3-treatment, 6-sequence, 3-period, crossover study, The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: HGP1201, Drug: HGP0904, Drug: HGP0904 and HGP1201 co-administraionA → B → C A: HGP1201 for 9 days B: HGP0904 for 9 days C: HGP1201+ HGP0904 for 9 days |
| Group 2 | Experimental | Drug: HGP1201, Drug: HGP0904, Drug: HGP0904 and HGP1201 co-administraionC → A → B |
| Group 3 | Experimental | Drug: HGP1201, Drug: HGP0904, Drug: HGP0904 and HGP1201 co-administraionB → C → A |
| Group 4 | Experimental | Drug: HGP1201, Drug: HGP0904, Drug: HGP0904 and HGP1201 co-administraionC → B → A |
| Group 5 | Experimental | Drug: HGP1201, Drug: HGP0904, Drug: HGP0904 and HGP1201 co-administraionB → A → C |
| Group 6 | Experimental | Drug: HGP1201, Drug: HGP0904, Drug: HGP0904 and HGP1201 co-administraionA → C → B |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteer, age 19~45 years
- The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
Key exclusion criteria (2 listed)
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
- History of relevant drug allergies or clinically significant hypersensitivity reaction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HGP1201 | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| HGP0904 | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| HGP0904 and HGP1201 co-administraion | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Cmax,ss of HGP1201, HGP0904
Time frame: 1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h
AUCτ,ss of HGP1201, HGP0904
Time frame: 1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyeong-Seok Lim, MD PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HGP1201, HGP0904 and HGP0904 and HGP1201 co-administraion in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax,ss of HGP1201, HGP0904 (time frame: 1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2016.